Section R12-1-606. Fluoroscopic and Fluoroscopic Treatment Simu- lator Systems

A.      Useful beam limitation. A registrant shall:

1.        Provide beam-limiting devices that restrict the entire cross section of the useful beam to less than the area of the primary barrier at any Source-to-Image Receptor Dis- tance (SID);

2.        Ensure that the x-ray field size produced by fluoroscopic systems without image intensification does not extend beyond the visible area of the image receptor at any SID;

3.        Ensure that the x-ray field size produced by fluoroscopic systems with image intensification and automatic shutter control does not exceed the diameter of the image recep- tor at any SID;

4.        Ensure that the x-ray field size produced by fluoroscopic systems with image intensification and manual shutter control does not exceed the diameter of the image recep- tor with the fluoroscopic imaging assembly positioned at the maximum usable distance above the table top; and

5.        Ensure that the x-ray field size produced by fluoroscopic systems with image intensification and manual shutter control, where the fluoroscopic tube is above the table top, does not exceed the diameter of the image receptor with the shutters open to the fullest extent, and at the maximum SID which the fluoroscopic tube is capable of producing radiation.

B.       Fluoroscopic primary protective barrier. A registrant shall:

1.        Provide the fluoroscopic imaging assembly with a pri- mary protective barrier that always intercepts the entire cross section of the useful beam at any SID.

2.        Ensure that the fluoroscopic tube is not capable of pro- ducing radiation unless the primary protective barrier is in a position to intercept the entire cross section of the useful beam.

3.        Ensure that fluoroscopic radiation production automati- cally terminates if the primary protective barrier is removed from the useful beam.

4.        Ensure that the fluoroscopic primary protective barrier meets the following requirements for attenuation of the useful beam:

a.         For equipment installed before November 15, 1967, the required lead equivalent of the barrier is not less than 1.5 millimeters for fluoroscopes that produce less than 100 kVp, 1.8 millimeters for fluoroscopes that produce at least 100 kVp but less than 125 kVp, and 2.0 millimeters for fluoroscopes that produce 125 or more kVp. (For conventional fluoroscopes, these requirements may be assumed to have been met if the exposure rate measured at the viewing sur- face of the fluorescent screen does not exceed 12.9 microcoulombs per kilogram (50 milliroentgens) per hour with the screen in the primary beam of the fluo- roscope without a patient, under normal operating conditions.) For equipment installed or reinstalled, the required lead equivalent of the barrier is 2.0 mil- limeters for fluoroscopes that produce less than 125 kVp or 2.7 millimeters for fluoroscopes that produce 125 or more kVp.

b.        For fluoroscopic systems that use image intensifica- tion, the exposure rate, due to transmission through the primary protective barrier, does not exceed 516 nC/kg (2 milliroentgens) per hour at 10 centimeters (4 inches) from any accessible surface of the fluoro- scopic imaging assembly, beyond the plane of the image receptor for each 258 µC/kg (1 roentgen) per minute of entrance exposure rate.

c.         Compliance with subsections (B)(4)(a) and (b) is determined with the image receptor positioned 35.5 centimeters (14 inches) from the panel or table top, at normal operating technical factors and with the attenuation block in the useful beam for systems with image intensification.

C.      Entrance exposure rate limits. A registrant shall ensure that:

1.        The exposure rate, measured at the point where the center of the useful beam enters the patient does not exceed 2.6 mC/kg (10 roentgens) per minute at any combination of

tube potential and current, except during recording of flu- oroscopic images or if provided with optional high-level control.

2.        If provided with optional high-level control, the equip- ment is not operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.6 mC/kg (10 roentgens)  per minute at the  point where the center of the useful beam enters the patient, unless the high-level control is activated, in which case an exposure rate in excess of 5.2 mC/kg (20 roentgens) per minute is prohibited.

a.         Special means of activation of high-level controls, such as additional pressure applied continuously by the operator, are required to avoid accidental use.

b.        A continuous signal audible to the fluoroscopist is required to indicate that the high-level control is being employed.

3.        The Agency shall determine compliance with subsections (C)(1) and (2) as follows:

a.         Remove grids and compression devices from the useful beam during the measurement;

b.        If the source is below the table, measure the expo- sure rate 1 centimeter above the table top or cradle; and

c.         If the source is above the table, measure the expo- sure rate 30 centimeters (11.8 inches) above  the table top with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;

d.        For fluoroscopy involving a  mobile C-arm  x-ray system, measure the exposure rate 30 centimeters (11.8 inches) from the input surface of the fluoro- scopic imaging assembly;

e.         For fluoroscopy involving a C-arm x-ray system, measure the exposure rate 30 centimeters (11.8 inches) from the input surface of the fluoroscope imaging assembly, with the x-ray source positioned at any available SID, provided that the end of the beam-limiting device or spacer is not closer than 30 centimeters (11.8 inches) from the input surface of the fluoroscopic image assembly; and

f.         For a lateral fluoroscope, measure the exposure rate 15 centimeters (5.9 inches) from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x- ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters (5.9 inches) to the centerline of the x-ray table.

D.      The registrant shall ensure that the source-to-skin distance is not less than:

1.        38 centimeters (15  inches)  on stationary fluoroscopes installed after January 2, 1996;

2.        35.5 centimeters (14 inches) on stationary fluoroscopes which are in operation before January 2, 1996;

3.        30 centimeters (11.8 inches) on all mobile fluoroscopes; and

4.        20 centimeters (8 inches) for image-intensified fluoro- scopes used for a specific surgical application. The regis- trant shall follow any precautionary measures in the users operating manual.

E.       Each fluoroscopic system installation is subject to all of the following requirements for the control of stray radiation. A registrant shall:

1.        Provide a shielding device of at least 0.25 millimeter lead equivalent for covering the Bucky-slot during fluoros- copy;

2.        Except for fluoroscopy performed using portable or mobile C-arm x-ray systems or during surgical proce- dures or cardiac catheterization, provide  protective drapes, or hinged or sliding panels of at least 0.25 milli- meters lead equivalent, between the patient and fluoros- copist to intercept scattered radiation that would otherwise reach  the fluoroscopist  and  others near  the machine, but not substitute drapes and panels for a pro- tective apron; and

3.        Ensure that protective aprons of at least 0.25 millimeter lead equivalent are worn in the fluoroscopy room by each person, except the patient, whose body is likely to be exposed to 50 µSv/hr (5 mR/hr) or more.

F.       Exposure control. A registrant shall:

1.        Ensure that activation of the fluoroscopic tube is con- trolled by a “dead-man” switch;

2.        Provide a manual reset cumulative timing device, which is activated only during production of radiation in the flu- oroscopic mode, to indicate elapsed time by an audible signal or terminate production of radiation;

3.        Provide a device for exposure control in the “spot film” mode that terminates exposure either automatically, or after a preset time interval, preset number of pulses, pre- set product of current and time, or preset exposure; and

4.        Ensure that the x-ray tube potential and current are con- tinuously indicated.

G.      A registrant shall provide systems used for mobile fluoroscopy with image intensification.

H.      Fluoroscopic  treatment  simulators.  Simulators   are  exempt from subsections (A) through (G). A registrant shall:

1.        Use a beam limiting device that restricts the beam to the area of clinical interest.

2.        Include and label devices for settings or physical factors, such as kVp, mA, or exposure time on the control panel;

3.        Ensure that the fluoroscopic exposure switch or switches are of the “deadman” type;

4.        Ensure that each person whose presence is necessary is in the simulator room during exposure and protected with a lead apron of at least 0.5 millimeter lead equivalent or a portable shield. Any person who places their hands in the useful x-ray beam shall wear leaded gloves; and

5.        Ensure that the operator stands behind a barrier and is able to observe the patient during simulator exposures.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-606 repealed, new Section R12-1-606 adopted effective August 8, 1986 (Supp. 86-4). Amended

effective January 2, 1996 (Supp. 96-1). Amended by final

rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 9 A.A.R.

4302, effective November 14, 2003 (Supp. 03-3).

Amended by final rulemaking at 15 A.A.R. 1023, effec- tive August 1, 2009 (Supp. 09-2). Amended by final

rulemaking at 19 A.A.R. 3882, effective January 4, 2014

(Supp. 13-4).